Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT00759018
Eligibility Criteria:
Inclusion criteria:
* Patients must sign an informed consent form (ICF) before any protocol-related procedures, including any pre-treatment procedures, are performed.
* Since patients being treated with Prochymal® under this protocol are under 18, a parental signature of informed consent will be required.
* Patients must be 2 months to 17 years of age, inclusive.
* Patients must have failed to respond to steroid treatment for Grades B-D acute GVHD • Failure to respond to steroid treatment for acute GVHD is defined as any Grade B-D acute GVHD that is not improving after at least 3 days of methylprednisolone (≥1 milligram per kilogram per day \[mg/kg/day\]) or equivalent.
Exclusion criteria:
* Patient must not have a known allergy to bovine or porcine products.
* Patient must not have received a transplant for a solid tumor disease.
* Patients must not have evidence of a pulmonary infiltrate or diffuse alveolar hemorrhage and must be unlikely to require more than 2 liters (L) of oxygen via face mask or an estimated fraction of inspired oxygen (FiO2) of 28% via other delivery methods in order to sustain an O2 saturation of 92% during the next 3 days.
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
17 Years
Study:
NCT00759018
Study Brief:
Protocol Section:
NCT00759018